Dear Dr. Dermatoethics: Why is diversity in clinical trials important?
Authors: Akash Rau, Jane M. Grant-Kels
Journal: Journal of the American Academy of Dermatology (2023)

Dear Dr. Dermatoethicist: Is diversity important in clinical trials? Is it ethical to use treatments in under-represented groups who have not been included in clinical trials?—Concerned Dermatologist Dear Dr. Dermatoethicist: Is diversity important in clinical trials? Is it ethical to use treatments in under-represented groups who have not been included in clinical trials? —Concerned Dermatologist Dear Concerned Dermatologist: Psoriasis clinical trials have included 85.2% of White patient participants.1Chen V. Akhtar S. Zheng C. Kumaresan V. Nouri K. Assessment of changes in diversity in dermatology clinical trials between 2010-2015 and 2015-2020: a systematic review.JAMA Dermatol. 2022; 158: 288-292Crossref PubMed Scopus (25) Google Scholar Only 60% of atopic dermatitis trials reported race, indicative of the exclusion of diverse populations.2Charrow A. Xia F.D. Joyce C. Mostaghimi A. Diversity in dermatology clinical trials: a systematic review.JAMA Dermatol. 2017; 153: 193-198Crossref PubMed Scopus (93) Google Scholar From 2010-2015 and 2015-2020, the percentage of dermatology-published clinical trials that included at least 20% SOC representation remained the same at 38.1%.1Chen V. Akhtar S. Zheng C. Kumaresan V. Nouri K. Assessment of changes in diversity in dermatology clinical trials between 2010-2015 and 2015-2020: a systematic review.JAMA Dermatol. 2022; 158: 288-292Crossref PubMed Scopus (25) Google Scholar Exclusion of minorities from clinical trials, intentional or unintentional, is unethical.3Taylor H.A. Inclusion of women, minorities, and children in clinical trials: opinions of research ethics board administrators.J Empir Res Hum Res Ethics. 2009; 4: 65-73Crossref PubMed Scopus (18) Google Scholar Factors contributing to the lack of participation include lack of willingness to participate, need to travel a great distance to participate, and pharmaceutical companies not prioritizing underrepresented groups. Inclusion of all skin types is important for the results of clinical trials to be generalizable.4Akintilo L. Pulavarty A. Onwudiwe O. Garibyan L. Lee K. Skin of color representation in cosmetic clinical trials: a literature review.Lasers Surg Med. 2022; 54: 819-822Crossref PubMed Scopus (8) Google Scholar Underrepresentation of diverse patients in clinical trials results in a lack of awareness of potential efficacy or adverse events that treatments might produce in these patients. There are known differences in the anatomy of various skin types, although some of these studies are limited and may not be generalizable to all underrepresented groups.5Wesley N.O. Maibach H.I. Racial (ethnic) differences in skin properties: the objective data.Am J Clin Dermatol. 2003; 4: 843-860Crossref PubMed Scopus (175) Google Scholar However, treatment of diverse patients with medications may not necessarily result in the outcomes reported in White patients. It is incumbent upon us to warn diverse patients that certain medications may have not been tested in underrepresented groups and to urge pharmaceutical companies to be more inclusive in future trials. Without clinical trials having been undertaken on a significant number of diverse patients, we cannot definitively preserve the beneficence and safety of our patients while trying to avoid nonmaleficence. We do not know how diverse patients will respond to a new treatment and if there will be unanticipated reduced efficacy or adverse side effects. However, it is unethical to not treat underrepresented patients with the best and newer medications. It is inherently unfair and additionally reflects a lack of justice as well as systemic inherent bias that to date clinical trial administrators have not made a greater effort to recruit underrepresented patients into clinical trials in proportion at least to their representation in our population. Finally, informed consent/truthfulness needs to be shared with these patients regarding new drugs that have not been trialed in underrepresented patients and that the outcome cannot be guaranteed. They have an autonomous right to know the risks they are taking and why (Table I).Table IEthical issues in treating underrepresented patients with therapeutics trialed on White SkinEthicsIssuesBeneficence•We cannot preserve the safety of our patients without clinical trials that include a variety of skin types. New clinical trials must be inclusive of all patients and include underrepresented patientsNonmaleficence•Underrepresented patients need to be treated for their skin disease and, therefore, it would be unethical to not prescribe these medications, even though these medications have not been adequately tested on varied skin type populationsJustice•Clinical trial administrators have not employed enough dedication to the recruitment of varied skin types into clinical trial participation in proportion at least to representation in our populationTruthfulness•Informed consent/truthfulness needs to be shared with these patients regarding the fact that past clinical trials were not inclusive of a significant number of patients with varied skin types•Outcomes for underrepresented patients may be different than was noted in clinical trials performed on predominantly White patientsAutonomy•Patients have an autonomous right to know the risks they are takingSOC, Skin of color. Open table in a new tab SOC, Skin of color. Although there has recently been greater awareness regarding the need to include underrepresented patients in clinical trials, those drugs approved before this have not been proven effective or safe in diverse patients. We need to make our underrepresented patients aware that although a greater effort is now ongoing to recruit participation of diverse patients in clinical trials, there has not been appropriate accrual of diverse patients in past studies2Charrow A. Xia F.D. Joyce C. Mostaghimi A. Diversity in dermatology clinical trials: a systematic review.JAMA Dermatol. 2017; 153: 193-198Crossref PubMed Scopus (93) Google Scholar and, therefore, their outcomes may not be the same as reported in the literature. Increasing diversity in the investigators involved in clinical trials and research could potentially help rectify this situation. Dermatologists should play an active role in appropriately referring our underrepresented patients to clinical trials and being advocates for increasing diversity in clinical trials. –Dr. Dermatoethicist None disclosed.